US FDA approves oral film formulation for treatment of rare seizure syndrome

Aquestive Therapeutics’ drug Sympazan (clobazam), an oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome​ (LGS) in patients 2 years of age or older, was approved by the US Food and Drug Administration (FDA) – offering a new treatment option for patients. Previously, the only other FDA approved version of clobazam was offered as a tablet or an oral suspension form.

Sympazan’s formulation is based on Aquestive’s PharmFilm technology. The oral film formulation was tested against oral tablet formulation in multiple pharmacokinetic studies and demonstrated bioequivalence to tablets, with comparable safety profiles.

A spokesperson for Aquestive told us that the company’s manufacturing facilities have produced more than 1 billion doses of medicine since 2014 using the PharmFilm technology. Sympazan will be produced at Aquestive’s facilities using the company’s proprietary patents.

According to Aquestive, patients with LGS, a severe form of epilepsy beginning in early childhood, often have a hard time swallowing pills or large volume of suspensions. The difficulties associated with drug administration can lead to inconsistent dosing and increasing challenges for patients and caretakers.

A spokesperson from Aquestive explained to us, “Sympazan is purposefully designed to meet the needs of patients with Lennox-Gastaut Syndrome​.”

“[Sympazan is] a lingual film that adheres to the tongue and quickly dissolves providing a simpler and more reliable way to dose the medication,”​ the spokesperson added.

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